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A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Trial Profile

A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2019

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Meniere's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Otonomy
  • Most Recent Events

    • 05 Nov 2019 According to an Otonomy media release, the company expects to results from this trial in the third quarter of 2020.
    • 28 Mar 2019 New source identified and integrated European Clinical Trials Database EudraCT2018-001464-35
    • 04 Mar 2019 According to an Otonomy media release, the design and conduct of this trial is based on the AVERTS-2 trial. The company expects to complete the trial in first half of 2020.
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